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WARNING LETTER
•Brenner Brothers & Sons•February 17, 2012

Brenner Brothers & Sons – FDA Warning Letter, Feb 17, 2012

Record Details

On February 1, 13, and 17, 2012, the FDA inspected Brenner Brothers & Sons' dairy operation in Hopkins, Michigan, and found violations of the Federal Food, Drug, and Cosmetic Act.

The FDA found that a cow sold for slaughter on June 9, 2011, with ear tag (b)(4) and back tag (b)(4), was adulterated. USDA/FSIS analysis of liver tissue from this animal, slaughtered on June 10, 2011, revealed sulfadimethoxine at 0.119 ppm, exceeding the 0.1 ppm tolerance (21 C.F.R. 556.640). This violates section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the operation held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

The firm also adulterated the new animal drug Di-Methox Injection ANADA 200-0

Company
Brenner Brothers & Sons
Inspection date
February 17, 2012
Product type
Drugs
Office
Detroit District Office
Person
  • Glenn T. Bass (Director)
View Company Profile

ID · 78e98da7-20a8-4db6-a7e5-a1a169cd280e

Violation Codes10
21 U.S.C. 342(a)(2)(C)(ii)21 U.S.C. 360(b)21 U.S.C. 342(a)(4)21 CFR 556.4021 CFR 530.3(a)21 U.S.C. 360b(a)(4)21 U.S.C. 360b(a)(5)21 CFR 53021 CFR 530.41(a)(9)21 CFR 530.11(d)

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